Aerosol devices and methods for inhaling a substance and uses thereof

ABSTRACT

Devices, cartridges, and method are described herein for emulating smoking wherein a device generates an aerosol for inhalation by a subject by heating a viscous material that can have a tactile response in the mouth or respiratory tract, while reducing Hoffman analytes and mutagenic compounds delivered to the user as compared to a common tobacco cigarette.

CROSS-REFERENCE

This application claims the benefit of U.S. Provisional Application No.61/014,690, filed Dec. 18, 2007, which application is incorporatedherein by reference.

BACKGROUND OF THE INVENTION

The use of tobacco products and the harmful side effects of smokingtobacco continue to gain increasing attention worldwide. As moreregulations come into effect regarding smoking in the work place or inpublic, interest in developing alternative products is growingsignificantly. One method of reducing the harmful side effects ofsmoking is to not burn the tobacco products. This is because many of theharmful analytes, such as Hoffman analytes, obtained from smoking arereceived due to the burning of the material.

A difficulty of developing and marketing a device that can deliver anaerosolized tobacco product is catering to the user in terms of visualand physical appeal of use. A device that can be used multiple times toaerosolize a variety of different substances while providing similarsensations to the user as those from smoking, such as visual vapor, aredesirable. A device and product that can aerosolize a tobacco productand reduce Hoffman analytes and mutagenic compounds delivered to a useras compared to smoking are also desirable.

SUMMARY OF THE INVENTION

In an aspect of the invention, a cartridge is disclosed for use in adevice for aerosolizing a material comprising: a shell for containing aviscous vaporizable material; and a lid sealed upon the shell, therebyforming a sealed cartridge containing the viscous vaporizable material.The lid can be penetrable, wherein a penetrated lid allows an exit of anaerosol generated from heating the viscous vaporizable material. The lidcan also be a heat-sealable film, wherein the heat-sealable filmcomprises a base layer and a heat-sealable layer. The shell of thecartridge or the lid of the cartridge can comprise aluminum. When ashell of a cartridge of the invention comprises a flange, a lid can besealed upon the flange.

The cartridge can be heated to a temperature required to aerosolize thematerial contained within the shell, preferably heated to a temperatureless than 400° F. The viscous vaporizable material within the cartridgecan comprise at least one of an aerosol-forming medium, propylene glycoland glycerin. The viscous vaporizable material can comprise tobacco.

The cartridge can be inserted into a device wherein the device iscapable of aerosolizing the viscous vaporizable material. The device cancomprise an oven chamber capable of heating the cartridge.

In order to mark a cartridge of the invention, information can beprinted on at least one of the shell and the lid.

In another aspect, a method of filling a cartridge containing a viscousvaporizable material comprises: loading the viscous vaporizable materialinto a shell of the cartridge; and sealing a lid on the shell of thecartridge. The method can be automated, for example, carried out on alinear or rotating indexing machine, or loaded using an auger filler,peristaltic pump or piston pump method. A predetermined volume ofviscous vaporizable material can be loaded in the loading step, whereinthe predetermined volume can be about 0.1 to about 0.8 cubiccentimeters. Preferably, the volume is about 0.25 cubic centimeters. Thesealing step of a method of filling the cartridge can comprise heatingat least one of the lid and the shell of the cartridge and trimming anyexcess material from the lid.

A device for generating an inhalable aerosol is provided hereincomprising: a body; a heater within said body capable of heating aviscous vaporizable material to generate an inhalable aerosol; andtemperature regulator comprising one or more bimetallic discs, whereinthe discs convert a temperature change into mechanical displacement. Theinhalable aerosol can comprise particles less than about 2 microns indiameter. The heater of the device can be supplied by gaseous fuel, suchas butane, and can be ignited by a piezoelectric igniter.

The discs of the temperature regulator can displace a pushrod thatlimits or ceases flow of the gaseous fuel within the body of the deviceby pushing on a variable flow-restricting valve. The pushrod can alsoprovide support for a catalytic mesh element.

In another aspect, the invention provides a device which emulatessmoking wherein the device generates an aerosol for inhalation by asubject by heating a viscous material containing plant matter to about150° C. and wherein the aerosol has a tactile response in the mouth orrespiratory tract. The viscous material can comprise an aerosol-formingmedium that can comprise at least one of propylene glycol and glycerinto produce a visual aerosol when heated. The viscous material can alsocomprise tobacco and flavorants.

The device can also deliver an active element to a user that is part ofthe aerosol. The active element can be absorbed in the respiratorytract. The aerosol can comprise particles less than about 2 microns indiameter.

Disclosed herein is a device of the invention comprising a body and aheater wherein the device generates a smokeless aerosol for inhalationby a subject by heating a viscous tobacco material to a targettemperature. The viscous material can comprise an aerosol-forming mediumthat can comprise at least one of propylene glycol and glycerin toproduce a visual aerosol when heated. The device can deliver an activeelement to a user that is part of the aerosol. The active element can beabsorbed in the respiratory tract. The aerosol can comprise particlesless than about 2 microns in diameter.

The target temperature for heating the viscous material in the devicecan be about 100° C. to about 200° C. Preferably, the target temperatureis about 150° C.

The device can also be operated by a user with a single hand.

In another aspect of the invention, an aerosol generating device isdisclosed wherein the device generates an aerosol substantially freefrom at least one Hoffman analyte upon heating a smokeable material to atarget temperature. The Hoffman analyte can be selected from the groupconsisting of: ammonia, aminonaphthalenes, benzopyrene, formaldehyde,acetaldehyde, acetone, methyl ethyl ketone, butyraldehyde, hydrogencyanide, nitrous oxides, tobacco-specific nitrosamines (TSNAs),pyridine, quinoline, hydroquinone, phenol, cresols, tar, nicotine,carbon monoxide, 1,3-butadiene, isoprene, acrylonitrile, benzene,toluene, and styrene.

The target temperature for heating the viscous material in the devicecan be about 100° C. to about 200° C. Preferably, the target temperatureis about 150° C., which generates an aerosol comprising particles lessthan about 2 microns in diameter.

The invention also provides an aerosol generating device wherein thedevice generates an aerosol upon heating a smokeable material to atarget temperature with at least 70% less Hoffman analytes than a commontobacco cigarette, and wherein the Hoffman analyte can be selected fromthe group consisting of: ammonia, aminonaphthalenes, benzopyrene,formaldehyde, acetaldehyde, acetone, methyl ethyl ketone, butyraldehyde,hydrogen cyanide, nitrous oxides, tobacco-specific nitrosamines (TSNAs),pyridine, quinoline, hydroquinone, phenol, cresols, tar, nicotine,carbon monoxide, 1,3-butadiene, isoprene, acrylonitrile, benzene,toluene, and styrene. The common tobacco cigarette can comprise afilter.

The target temperature for heating the viscous material in the devicecan be about 100° C. to about 200° C. Preferably, the target temperatureis about 150° C. and generates an aerosol comprising particles less thanabout 2 microns in diameter.

In an aspect, the invention discloses a method of delivering an aerosolsubstantially free from a Hoffman analyte to a subject comprising:deploying an aerosol generating device containing a heater and asmokeable material; heating the smokeable material with the heater ofthe device to a target temperature to generate an aerosol; anddelivering the aerosol to the subject for inhalation.

In another aspect, a method of creating a tactile response in the mouthor respiratory tract is disclosed. The method comprises: deploying asmoke emulating device wherein the device generates a smokeless aerosolhaving a tactile response in the mouth or respiratory tract by heating aviscous material containing plant matter contained therein; heating theviscous material to a target temperature; generating an aerosol havingthe tactile response in the mouth or respiratory tract from the heatedviscous material; and inhaling the aerosol. The viscous material cancomprise an aerosol-forming medium that can comprise at least one ofpropylene glycol and glycerin to produce a visual aerosol when heated.The viscous material can also comprise at least one of tobacco andflavorants. The device can deliver an active element to a user that ispart of the aerosol. The active element can be absorbed in therespiratory tract. The aerosol can comprise particles less than about 2microns in diameter.

In another aspect, the invention discloses an aerosol generating devicewherein the device generates an aerosol from a smokeable materialwherein the aerosol contains at least 70% less Hoffman analytes than asubstance generated by burning the smokeable material is provided by theinvention.

Also disclosed is an aerosol generating device wherein the devicegenerates an aerosol from a smokeable material that passes the Amestest, and an aerosol generating device wherein the device generates anaerosol from a smokeable material wherein the aerosol scoressignificantly better on the Ames test than a substance generated byburning the smokeable material.

The invention provides an aerosol generating device wherein the deviceprovides an aerosol for inhalation to a user for at least 4non-continuous hours without replenishing fuel or otherwise servicingthe device.

INCORPORATION BY REFERENCE

All publications, patents and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent or patent application wasspecifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

A better understanding of the features and advantages of the presentinvention will be obtained by reference to the following detaileddescription that sets forth illustrative embodiments, in which theprinciples of the invention are used, and the accompanying drawings ofwhich:

FIG. 1 illustrates a device of the invention comprising a mouthpiece anda body having a heater, an oven chamber, a fuel tank, and an igniterwith controller for maintaining the operating temperature;

FIG. 2 illustrates a device of the invention comprising a fuel tank thatis meant to be refillable, and has a port for that purpose;

FIG. 3 illustrates a device of the invention comprising a heaterassembly, which can be powered by any combustible fuel, and a series ofbimetallic objects to control the flow of the combustible fuel to heaterassembly;

FIG. 4 demonstrates a device wherein fuel is supplied to the tankthrough a filling valve and compressed liquid fuel can be drawn for useby a wick;

FIG. 5 illustrates a device of the invention comprising a singleelastomeric stopper which prohibits the movement of gas and wherein theflow of gaseous fuel is limited by a compressed foam flow restrictor andmay only leave through a valve orifice;

FIG. 6 demonstrates a device in which the plastic body exhaust aperturesare located above the heater exhaust apertures and the escaping gas mustpass along the heater body and exchange even more of its heat, therebyimproving efficiency of the device;

FIG. 7 illustrates a device of the invention with a hinged mouthpiece;

FIG. 8A demonstrates a device wherein the user can slide a strip ofmaterial towards the mouthpiece end of the device to turn it on, andthen slide the strip back towards the fill port to turn it off;

FIG. 8B illustrates the device of FIG. 8A from a different perspective;

FIG. 9 illustrates a cartridge that can contains a moist vaporizableproduct for use with a device capable of vaporizing the productcomprising a shell, a lid, and a flange for adhering the lid to theshell;

FIG. 10 shows a basic heat-sealable film with PET base layer and APETheat-sealing layer;

FIG. 11 shows a composite film with a PET base layer and APETheat-sealing layer, but with additional metal layer and metal adhesionlayer;

FIG. 12 illustrates a cartridge of the invention containing a moistvaporizable product and comprising apertures or vents to allow thecontent within the cartridge to have access to the environment;

FIGS. 13A-B illustrate cartridges with two portions that can fittogether and may have apertures or vents for releasing a vapor from thecontents of the cartridges;

FIG. 14 demonstrates an exemplary method of use of a device of theinvention that can emulate smoking by still providing many of thedesirable effects of smoking required by a user while reducing Hoffmananalyte intake;

FIG. 15 demonstrates an exemplary method of use of a device of theinvention wherein the user has received inhaled tobacco substances froma device of the invention in a manner that has reduced the Hoffmananalyte intake of the user by at least 70% and the user may exhale avisible vapor from the vapor-forming medium to provide a similar visualaide to that of exhaled smoke in the act of smoking; and

FIG. 16 shows the results of a bacterial mutagenesis test (Ames assay)indicating that particulate generated by smoking the device of thepresent invention is non-mutagenic.

DETAILED DESCRIPTION OF THE INVENTION

The invention described herein has a wide range of applications forinhalation of an active substance as will be appreciated by persons ofskill in the art upon reviewing the disclosure. For example, thedevices, cartridges, systems, kits and methods could be used, forexample, to inhale a tobacco product through the mouth or nose. Thedevices, cartridge, systems, kits, and methods could also be used toreduce the Hoffmann analytes provided to user by inhaling a tobaccoproduct, as compared to smoking or burning of tobacco. Additionally, thedevices, systems, kits and methods could be used, for example, to inhaleany substance, such as a botanical, pharmaceutical, nutraceutical, orany other substance providing a benefit or sensation to an end user.

I. Aerosol Generating Device

An exemplary device of the invention is illustrated in FIG. 1. Thedevice 100 is capable of creating temperatures high enough to aerosolizea product contained within the device 100. A device of the invention cancomprise a mouthpiece 110 and a body 120 having a heater 122, an ovenchamber 124, a fuel tank 126, and an igniter with controller formaintaining the operating temperature. Examples of operating temperatureregulators of a device include a bimetallic actuator. Alternatively, aparaffin-filled component that expands and contracts to modulate butaneflow could be employed. Alternatively, a system could be employed tomeasure the current temperature, for example, with a thermocouple sensorand compare it to a prescribed temperature, for example, with amicro-controller, and by controlling an electromechanical valve, forexample, servo or solenoid valve. A user-selected temperature, asdescribed above, the selected temperature could be used as an input tothis system.

A device can be constructed without an active regulating element. Thiscan result in reduced complexity and in lowering the overall cost ofmanufacture of the device. For example, the flow of fuel to the heater122 can be set at a low level. In use, the temperature inside the ovenchamber 124 increases until an equilibrium point where additional heatintroduced equals the heat lost to the environment. Heat is lost byconduction through the body of the device 100, and with the vapordelivered to the user. This equilibrium point determines the operatingtemperature of the device 100. By changing the fuel flow rate, size andmaterial of the burner, and other factors, the system can be calibratedto provide a fairly stable desired operating temperature.

A piezo-electric igniter can be used. Other igniters can be used, suchas, a flint starter or battery-powered resistive coil.

As illustrated in FIG. 2, a device 200 of the invention can alsocomprise a fuel tank 226 that is meant to be refillable, and has a port230 for that purpose. The tank 226 can be disposable once its fuel isexhausted. A release mechanism such as a pin or cam can be employedallowing the user to quickly remove the depleted tank 226 and replace itwith a full tank. A replaceable tank might include additional parts ofthe device such as the igniter and heater. A liquid fuel is thepreferable fuel source, however the liquid fuel can be complimented orreplaced by a battery-powered electric heater or other compact heatsource. The tank 126 can be filled by a fill valve mechanism 128 asshown in FIG. 1 with a specialized fuel source or a standard commercialfuel source.

The fuel tank can hold enough fuel for repeated uses of the device. Thedevice can be used for up to 10, 20, 30, 40, 50, or 60 uses. In someembodiments, the device can be used for more than 60 uses. The devicecan also be used for up to 1, 2, 3, 4, 5, 6, 7, or 8 hours of continuousor non-continuous use. A cartridge for use with the device can bedisposed after each use or used for multiple uses. The long lasting useof a device of the invention provides the user the advantage of nothaving to service the device or refill the fuel tank on a regular basis.The advantage of multiple uses can be preferably obtained by using alarger sized fuel tank and/or the use of butane as a fuel, which canproduce the necessary temperatures to use the device in an efficientmanner.

Typically, the operating temperatures of the device are no more than200° C. Often the temperature required to aerosolize a product isbetween about 100 to 200° C. In some embodiments, the temperaturerequired to aerosolize a product is about 150° C. Once the productwithin the device has been aerosolized, the aerosolized product isprovided to a user through a mouthpiece. In many cases, a device of theinvention is designed to emulate a smoking device, such as a cigarette,a pipe or a cigar holder.

In FIG. 3, the device 300 comprises a heater assembly 322, which can bepowered by any combustible fuel, and a series of bimetallic objects 332to control the flow of the combustible fuel to heater assembly 322.Examples of combustible fuel include, but are not limited to, propane,butane, methane, and ethanol. As the device 300 heats up, or a portionof the device 300 heats up, the bimetallic objects 332 change theirshape (for example, from flat to concave or convex) in order to regulatethe amount of fuel entering the heater assembly 322. This can occur byvariety of mechanisms, including pushing a rod 334 (pushrod 334 asreferred to herein) against a variable flow valve 336 as shown in FIG.3.

A bimetallic object can be used to convert a temperature change intomechanical displacement. The object comprises two different metals whichexpand at different rates as they are heated, for example, steel andcopper. The object can be an alloy or two metals that have been securedtogether. The bimetallic objects can be of any planar shape, such as asquare, rectangle, or strip. Preferably, the bimetallic objects arebimetallic discs. The different expansions force the flat object to bendone way if heated, and to bend in the opposite direction if cooled. Thebimetallic objects can be bimetallic discs such as the commerciallyavailable Truflex P675/700 discs.

The mechanical displacement of a bimetallic object is much larger thanthe small lengthways expansion in either of the two metals. This effectis used in a range of mechanical and electrical devices. In most of theexample devices of the invention, the bimetallic object is used in theplanar form. In others, it can be wrapped into a coil for compactness.

Nickel titanium (NiTi) is a shape memory alloy also commonly referred asNitinol. Above its transformation temperature, Nitinol is superelasticand able to withstand a large amount of deformation when a load isapplied and return to its original shape when the load is removed. Belowits transformation temperature, it displays the shape memory effect.When it is deformed it will remain in that shape until heated above itstransformation temperature, at which time it will return to its originalshape. Nitinol is typically composed of approximately 55% Nickel byweight. Making small changes in the composition can change thetransition temperature of the alloy significantly. These uniqueproperties and tailorability of Nitinol to be used in a wide range oftemperatures makes it suitable as substitute for the bimetallic objectof the present invention. As will be appreciated by those skilled in theart other shape memory alloys can be used without departing from thescope of the invention.

The use of alternately-stacked bimetallic discs in a device of theinvention is not only a simple and cheap solution for fitting a thermalregulation scheme into a very small space, but also has some keyadvantages over other methods of thermal regulation. The discs are amodular solution, meaning that different numbers of discs can be used totune the temperature sensitivity of a device. Using multiple discsinstead of one disc allows longer overall travel for a given (small)diameter of disk. Thinner or thicker discs can also be used for the samepurpose, or to add additional ability to exert force. Since the domingshape of the discs is particularly strong, the varying pressure of thefuel will have minimal effect on the regulation temperature. Also, sincethe bimetallic stack is a non-discrete, continuously acting system, thedevice can have a dampened regulation effect by using the roughened-seatdesign mentioned above, making the device much less likely toself-extinguish. The discs also respond to a temperature at a pointnearest the oven of the device so that the oven is held at the mostconstant temperature possible.

FIG. 4 demonstrates a detailed example of some components of a device400 of the invention. In FIG. 4, fuel is supplied to the tank 426through a filling valve 428 and compressed liquid fuel can be drawn foruse by a wick 438. In the example in FIG. 5, the flow of gaseous fuel isthen limited by a compressed foam flow restrictor 540 and may only leavethrough a valve orifice 542. There is a single elastomeric stopper 544which prohibits the movement of gas. The use of a single stopper 544 forall gas flow regulation can increase the simplicity and reliability ofthe system significantly. The stopper 544 is also referred to herein asa variable flow valve 544. Also included can be a simple but separatemeans for regulating butane flow with temperature, dispensing anextremely low flow of gas to keep a portion of catalyst above itslight-off temperature, and allowing the user to turn on and off thedevice 500. The variable flow valve 544 can allow all three of theseneeds to be handled by a single valve.

The stopper 544 can be connected to a rigid jetting assembly terminatingwith an electrically insulating component 546. The jet assembly isnormally held in a position that allows gas to exit the valve orifice542 and to enter the jet assembly by a relatively low spring constantbiasing spring 548. Gas is limited to only entering the jet assembly bya sliding seal 550. Alternately, a flexible diaphragm could be used. Theuser is able to defeat this normal flow of gas by sliding an activatingslider so that the jetting assembly is held down such that the stopper544 seals the valve orifice 542; this is the OFF state of the device500. When the user allows the normal gas flow state by sliding anactivating slider to the ON position a piezo-igniter is depressed sothat a spark is generated between the jet rosette 552 and the ovenheater 522, thereby igniting the flowing gas. As the oven heater 522begins to reach its operating temperature a series of alternatelystacked bimetal discs 532 change shape (transitioning from flat todomed) and act on a pushrod component 534 which in turn presses the jetassembly so that the stopper 544 limits or ceases the flow of gas.

By using a bimetallic disc design, a device of the invention may betuned to a specified temperature regulating range by simply changing thedistance between the backstop of the discs and the valve seat. In FIGS.4-5, by threading the oven heater component 422, 522 into the plasticbody 420, 520 of the device 400, 500, the operating temperature can bechanged by simply twisting the oven component 422, 522 externally usinga tool that mates with the oven. The oven 424 can also be designed to bemoved manually by a user. Features can also be incorporated onto theoven 424 for twisting the component.

In FIG. 5, the pushrod component 534 can serve multiple functions. Thepushrod 534 can act to transfer longitudinal motion of the bimetallicdiscs 532 to the jet assembly, which in turn transfers that motion tothe valve stopper 544. The pushrod 534 can also hold the catalyst in aneasily assembled manner, such as the catalyst being simply wound aroundthe pushrod 534. The pushrod 534 designates a fixed space between thejet rosette 552 and the catalyst, so that initial combustion can easilyoccur. In an example, the pushrod 534 has roughly the shape of adumbbell, with two flat, circular surfaces at opposing ends which areused to contact the bimetallic discs 532 at the top, and the insulatingcomponent 546 at the bottom. The lower end of the pushrod 534 has largecutouts which allow for gas flow to pass through and initial combustionto take place.

Many devices of the invention use a temperature regulation scheme inthat the temperature regulator (bimetallic discs) are located in closeproximity to the area where temperature is most critical (at the oven).Related art has typically located the temperature-sensitive component atthe flow valve, which can be easily influenced by the cool temperatureof expanding fuel gas and has minimally intimate contact with thevaporizing chamber. Examples of related devices and methods aredescribed in U.S. patent application Ser. No. 11/485,168, U.S. Pat. No.4,819,665, U.S. Pat. No. 4,793,365, U.S. Pat. No. 5,027,836 and PCTApplication WO 2006/082571. The regulation scheme of a device of theinvention may be tuned to a specific temperature by a simple twist ofthe oven.

In the exemplary devices of FIGS. 4-5, air enters the jet assemblythrough inlet apertures 454, 554 and mixes with the butane flow path atthe venturi 556. Exhaust gas exits through outlet ports 458.

The user is prevented from touching the hot internal elements bysurrounding insulating features. A device of the invention can includeinsulation for keeping the user from contacting the necessarily hotportion of the device. While greater thermal insulating ability ispreferable so that the device performs with the best efficiencypossible, an important aspect for the user is to perceive a relativelycool surface temperature. Various strategies can be employed to addressthe perception of the user regarding the temperature of the device. Thedevice may be wrapped in a thermal insulating material that has enoughdurability for external use. Materials for this purpose have low thermalconductivity and low thermal capacity (specific heat). The combinationof these properties can allow little heat to be transferred to thefingers of the user. Examples of materials with low thermal conductivityand capacity include some polymers and ceramics. A separate strategy isto use standoff features that keep the user from touching the highertemperature area directly. This can also minimize the contact area ofthe user's fingers and the device to additionally reduce perceived heat.The thermal conductivity and specific heat of the standoff featuresshould be as low as possible.

A heater of a device of the invention can comprise a conductive shelland a catalyst, wherein the shell may be of one or more material formedby welding or pressing together. The catalyst within the heater can bechosen to provide an efficient flameless combustion of the fuel. In somecases, in order to provide a visual clue to the user, the catalyst orheater can emit a color, such as red, when the heater is heating toindicate that the device is activated.

In some cases, the heater can exhaust directly to the surroundingatmosphere through a side aperture. However, as demonstrated in FIG. 1 adevice 100 of the invention preferably incorporates a series of smallerapertures 158 around the heater assembly 122 which better transfer heatfrom the catalyzed gas to the oven 124. Also, as shown in FIG. 6, sincethe plastic body 620 exhaust apertures 662 are located above the heaterexhaust apertures the escaping gas must pass along the heater body andexchange even more of its heat, improving efficiency of the device 600.The use of two barriers (heater wall and body wall), in conjunction withstaggering the vent apertures, has the added benefit of improvingwind-resistance (for example, ambient wind is less likely to disturb theinternal flow of gases, or cool the catalyst to the point that itextinguishes.) The specific geometry of the exhaust path allows forthese benefits without inhibiting the initial combustion of gasnecessary to initiate catalytic activity. The gas flows smoothly througha continually expanding exhaust area, without torturous turns that couldcause the initial burst of gas to extinguish itself.

In the field of combustion catalysts, the light-off temperature is oftenused to describe the minimum temperature at which the catalyst must bemaintained in order to catalyze the exothermic reaction of fuel andoxidant. Only a portion of the catalyst must remain at this temperatureto prevent the reaction from extinguishing altogether. The targetedoperating temperature of a heater of a device of the invention is closeto the light-off temperature of most catalysts, and can make maintainingthe catalyst difficult to achieve. The target operating of temperatureof the heater can be 180° C. Examples of types of catalysts used in adevice of the invention include, but are not limited to, platinum,palladium, and rhodium. The catalyst light-off temperature of a catalystfor use with the invention may be from about 100 to 200° C.

To address the fine difference in temperature of the heater as comparedto the light-off temperature a small trickle of gas can flow over thecatalyst and/or the catalyst can be shielded from external factors, suchas wind. A device of the invention can include a protected exhaust path,meaning that exhaust does not directly exit to the outside air butinstead travels along a convoluted path so that the catalyst isdifficult to extinguish by wind.

A concern for the reliability of the device of the invention is tomaintain catalyst operation at the low target temperatures of thedevice. A discrete on/off valve alone can have difficulty in this regardbecause the cycle time between butane bursts can sometimes allow thecatalyst to cool to too low of a temperature, and a rapid burst ofexpanding butane can actually serve to extinguish the catalyst since thebutane temperature will be cool. A simple solution that can beincorporated into a device of the invention is to slightly roughen thevalve seat surface, or to use a textured stopper surface so that thedevice can achieve a low-flow of butane just before it closes the flowcompletely during regulation. This is similar in operation to a needlevalve, but much cheaper and easier to implement. A needle valve can alsobe used in a device of the invention to regulate fuel flow. Some priorart uses a thermal mass so that the light-off temperature can bemaintained between regulation intervals. When gas flow resumes betweenregulation intervals only the area in contact with the thermal mass willinitially catalyze the gas, exhausting a reasonable amount of unusedfuel. A device of the invention does not require such a thermal masssince the valve seat can act as an analog valve and allow the device todampen regulation intervals and intensity. A device of the invention cantrickle an amount of butane needed to keep the catalyst above light-offtemperature, in other words, not overwhelming the catalyst.

As demonstrated in FIG. 3, a device 300 of the invention can be usedaerosolize a material contained within a cartridge 370 that can beinserted into the oven chamber 324 of the device 300. With the spark ofan igniter (immediately following the start of gas flow), the gasignites and heat starts conducting throughout the heater assembly 322.Heat transfers to the cartridge 370 by conduction, convection, and/orradiation. The cartridge 370 can be shaped to fill the chamber 324 so asto maximize surface contact for thermal conduction. As the cartridge 370heats, vapor generates within the cartridge 370 and in the spaceimmediately above it. When a user draws on the device 300, fresh airenters through an air inlet, mixes with the vapor, and the mixture isdelivered to the user via the inhalation passage. The air inlet orinlets can be directed downward, so as to improve the extraction ofvapor from the cartridge 370. The air inlet can also be directed along adiagonal through the mouthpiece 310, or laterally through the caseitself, above the cartridge 370. The air inlet or inlets can have adiameter and direction sized to admit ambient air into the chamber 324to stir up vapor while not affecting the operating temperature. The airinlet apertures can also regulate the velocity of ambient air enteringand mixing with the vapor generated in the oven chamber 424 at either aset rate or a rate chosen by the user. For example, the rate of airentering the device 300 can provide a perception to the user as if thesmoke is drawn through a cigarette. Once the cartridge 370 is used, thedevice 300 can be turned off and the cartridge 370 is removed by openingthe oven chamber 324 of the device 300. The cartridge 370 can be removedby hand or by a mechanism that can quickly and easily remove thecartridge 370. This mechanism can include the use of a pin or slide partto eject the cartridge 370 as another part of the device 300 is moved orremoved. The removal mechanism could also involve introduction of aforeign object.

A device as shown in FIG. 7 can incorporate a mouthpiece 710 that isconnected to the body 720 of the device 700. The mouthpiece 710 can be ahinged component. The mouthpiece 710 can also be manufactured such thatit securely fits into place when it is closed onto the device body 720.The device 700 can be intended for use with a cartridge 770 of theinvention as is described herein. A cartridge 770 can be inserted intothe oven chamber 724 of a device 700 of the invention. As demonstratedin FIG. 7, the mouthpiece 710 can be removed, or hinged open, to provideaccess to the oven chamber 724 and wherein a cartridge 770 containing amaterial to be aerosolized can be inserted. The mouthpiece 710 of thedevice 700 can also be removable or removable and configured for onetime use. In this way, multiple users could use the same device 700 buthave interchangeable mouthpieces 710. Or if a mouthpiece 710 was soiled,another mouthpiece 710 could easily replace it to prevent having todispose of the entire device 700. When the device 700 incorporates amouthpiece 710 that is connected to the body of the device, such as ahinged mouthpiece 710, the device 700 can be operated by a single handof a user.

A mouthpiece can be made of a high-temperature and food-safe materialsuch as ceramic, glass, or various high-temperature plastics such aspolyimide thermoplastic resins, polyetherimide (PEI) resin (brand nameUltem®). Design is simplified by use of high temperature materials, butstandard plastics or wood, could also be used with the addition of aninsulating component that prevents excessive heat from reaching theuser, e.g., the user's lips. Additionally, a mouthpiece can be extendedin length, such that the temperature at the mouth of the user issubstantially lower than the end of the mouthpiece close to the sourceof heat.

The mouthpiece 710 of a device 700 of the invention, such as the examplein FIG. 7 can include a puncturer 712 for piercing a sealed cartridgecontaining a material for use with the device 700. For example, a hingedmouthpiece 710 can be opened, a cartridge 770 inserted into the device700, and the mouthpiece 710 can then be closed, which punctures thecartridge 770 for use with the device 710. The puncturer 712 can be anyobject as would be obvious to one skilled in the art. Preferably thepuncturer 712 is a small protuberance 712 that is molded into amouthpiece 710 and which terminates in a point or edge 714 forpuncturing the cartridge 770 when a small amount of force is applied.

Some related art devices require two hands for ignition, leading to aclumsy user experience. Preferably a method of ignition using a deviceof the invention allows for single-handed ignition. As shown in FIGS.8A-8B, the user can press a button 802 on the device 800 to turn it on,and then press the button 802 again to turn it off. In otherembodiments, the user can slide a strip of material towards themouthpiece end 810 of the device 800 to turn it on, and then slide thestrip back towards the fill port to turn it off. Other components can beincorporated into a device of the invention as would be obvious to oneskilled in the art, such as a switch. A mechanical advantage may beprovided to the user in order to activate an igniter without undue forcefrom the user. Examples of a mechanical advantage include, but are notlimited to, levers, four-bar linkages, and other devices as would beobvious to those skilled in the art.

A device of the invention may also provide additional user friendlyadvantages. For example, the bimetallic object temperature regulatorallows for the device to be of a slim, compact, and thus appealing form.Thermal insulating methods prohibit the user from being startled by highheat. A simple on/off mechanism allows for the user to begin and end theuse session using a single hand.

II. Cartridge

FIG. 9 demonstrates a cartridge 970 that can contains a moistvaporizable product 972 (also referred to sometimes herein as a viscousvaporizable material, a fluidic vaporizable material, a moist smokeablematerial, a fluidic smokeable material, or moist vaporizable content)for use with a device capable of vaporizing the product 970. In thefigure, the cartridge 970 contains a shell 974 that is sealed with a lid976. In this example, the shell 974 comprises a flange 978 for adheringthe lid 976 to the shell 974. The shell 974 of the cartridge 970 or theentire cartridge 970 can be made from a variety of materials including,but not limited to, metals, rigid plastics, flexible plastics, paper,paperboard, cardboard, and wax paper. The shell 974 of the cartridge 970typically comprises a food-safe material, as in most cases, thecartridge 970 is to be used with a device for inhalation of a substanceby a subject. Examples of some food-safe materials include aluminum,stainless steel, polyethylene terephthalate (PET), amorphouspolyethylene terephthalate (APET), high density polyethylene (HDPE),polyvinyl chloride (PVC), low density polyethylene (LDPE),polypropylene, polystyrene, polycarbonate, and many varieties of paperproducts. In some cases, especially when the material is paper, theshell 974 can be lined with a material or a food-safe material toprevent both drying of the moist vaporizable content 972 and to protectthe moist vaporizable content 972.

Preferably a cartridge formed and shaped for easier insertion into anoven chamber of a device of the invention and to snugly fit into thecavity of the oven chamber for improved thermal conduction andvaporization. Cartridges can be formed and wrapped in a process thatdoes not produce significant amount of harmful gases.

A shell of a cartridge can be lidded with, for example a heat-sealablelidding film, to make a fully enclosed and airtight cartridge. A sealedcartridge of the invention can have the advantage of preservingfreshness of the contents, and preventing spill of the materials withinthe cartridge during shipment or handling by the user.

The lid of a cartridge can also be made by a variety of materials.Typically, the lid comprises a food-safe material. The lid can be sealedonto the cartridge after the moist vaporizable content is inserted intoa cartridge of the invention. Many methods of sealing the lid upon theshell of a cartridge are known to those with skill in the art. Oneexample of a method of sealing the lid on a shell of a cartridgecomprising a flange is heat sealing. Preferably, the lid of thecartridge is considered food-safe to at least about 400° F. The lid canbe a commercially-available film for use with foods cooked in aconventional oven, and are often referred to as dual-ovenable (formicrowave and conventional oven use). The dual-ovenable films typicallycomprise of a PET (polyethylene terephthalate) base layer and an APET(amorphous polyethylene terephthalate) heat-sealing layer. Such liddingfilms can readily be metallized, or foilized in advance, preferably withaluminum to improve the barrier performance of the film regardingmoisture, oxygen and other gases. Metallized films can be produced bycommon converting processes known to those skilled in the art.

For illustration, FIG. 10 shows a basic heat-sealable film 1076 with PETbase layer 1080 and APET heat-sealing layer 1082. FIG. 11 shows acomposite film 1176 with a similar PET base layer 1180 and APETheat-sealing layer 1182, but with additional metal layer 1184 and metaladhesion layer 1186. In both cases, the APET heat-sealing layer 1182 iswhat comes in contact with a flange of a shell of a cartridge of theinvention.

The material of a cartridge of the invention and the shell can serve topreserve the freshness of the fill material, and increase shelf life ofthe cartridges. A metallized cartridge or lid or shell can also improvethe visual appeal and perceived value of the cartridges. The material ofthe cartridge can also allow for improved printing and visibility ofproduct information such as brand and indication of flavor.

A cartridge 1270 of the invention that contains a moist vaporizableproduct can have apertures or vents 1288 in the cartridge 1270, asdemonstrated by the example cartridge 1270 in FIG. 12. These apertures1288 can allow for the content within the cartridge 1270 to have accessto the environment. Some types of contents may need or find the accessto the environment advantageous.

The exemplary cartridge 1270 in FIG. 12 may also be composed of amaterial that can be punctured or opened when put into a device capableof vaporizing the contents of the cartridge 1270. For example, if acartridge 1270 is heated to a certain temperature, the contentsvaporize, and the aperture or apertures or openings 1288 created by thedevice allow the vapor content from the heated cartridge 1270 to escape.In a different manner, the cartridge 1270 may comprise a lid or a seal1276 that can be opened immediately prior to the cartridge 1270 beinginserted within a device.

The portions of a cartridge can be of FIG. 13A, a cartridge 1370 withtwo portions 390, 1392 can be fit together, or have a mechanism forsealing the two portions 1390, 1392 together. FIG. 13B demonstrates acartridge 1370 that is put together, with each portion containingapertures or vents 1388 for releasing a vapor from the contents of thecartridge 1370 when the cartridge 1370 is heated.

In many cases, a cartridge of the invention is intended for a single useand to be disposable. However, some types of cartridges, such as thosethat have methods for seating two portions together, could be usedmultiple times as a reusable cartridge.

A cartridge can be provided or sold to an end user containing a singleuse of a moist vaporizable product. The type of product contained withinthe cartridge can be stamped or written on the cartridge, or indicatedby the color, size, or shape of the cartridge. However, a cartridge canbe filled by an end used with a moist vaporizable product.

As intended for use by the end consumer, a sealed cartridge of theinvention can be inserted into the oven chamber of the device of theinvention. The mouthpiece of the device is then returned to the closedposition, at which point it can puncture the film on the top of thecartridge. Vapor generated by the heating process is then allowed toexit the cartridge and be inhaled by the user through the mouthpiece.

III. Aerosolized Materials

Any material that is capable of being aerosolized and inhaled by a usermay be incorporated into a device or cartridge of the invention as wouldbe obvious to one skilled in the art. It is of particular interest thatthe material provides an experience to the user either in terms oftactile response in the respiratory tract, or in terms of visualfeedback regarding the exhalation of the inhaled material. For example,many materials have be contemplated for use with the present inventionincluding, but not limited to, those containing tobacco, natural orartificial flavorants, coffee grounds or coffee beans, mint, chamomile,lemon, honey, tea leaves, cocoa, and other non-tobacco alternativesbased on other botanicals. A device or cartridge of the invention canalso be compatible for use with pharmaceutical compounds or syntheticcompounds, either for pharmaceutical or pleasurable use. Any suchcompound which can be vaporized (or volatized) at a relatively lowtemperature and without harmful degradation products can be suitable foruse with a cartridge or device of the invention. Examples of compoundsinclude, but are not limited to, menthol, caffeine, taurine, andnicotine.

Active elements contained in botanicals vaporize at differenttemperatures. The device can be calibrated to establish a single stabletemperature, intended for vaporizing specific products, for example. Acontroller can also be used to select a variety of temperature settings.The user would choose which setting based on the type of cartridge used.The controller can also affect a desired temperature mechanically, suchas by changing flow rate of the valve, or electronically, such as byelectromechanical valve and micro-controller intermediary. For example,to change the operating temperature of a device of the invention, theoven chamber can be moved in respect to the temperature regulator, suchas bimetallic discs.

Here, tobacco or tobacco material is defined as any combination ofnatural and synthetic material that can be vaporized for pleasure ormedicinal use. In one embodiment of the present invention, a cartridgecan be prepared using cured tobacco, glycerin, and flavorings. Thoseskilled in the art of tobacco product manufacture are familiar withthese and other ingredients used for cigarettes, cigars, and the like.The cartridge can be produced by chopping tobacco into fine pieces (forexample, less than 2 mm diameter, preferably less than 1 mm), adding theother ingredients, and mixing until even consistency was achieved. Inanother embodiment, a cartridge can be prepared by processing the fillmaterial into an even paste-like consistency (for example, particle sizeless than 1 mm), which facilitates the processing of filling thecartridge, for example, by use of an auger filler, peristaltic pump or apiston pump.

Preferably the material for use with a device of the invention orcontained within a cartridge of the invention comprises at least one ofa vapor-forming medium and a medium for providing a tactile response ina respiratory tract of a user. The aerosolized product from the materialinserted into a device can be a combination of vapor phase gases as wellas small droplets which have condensed out of vapor phase and remainsuspended in the gas/air mixture (the latter constitutes the visibleportion of the inhaled substance).

Propylene glycol (PG), glycerin, or a combination of both can be used asvapor-forming medium. Other vapor-forming media can be used with acartridge and device of the invention. The vapor-forming medium servesto produce a visual vapor, such as a smoke-like vapor, when heated. Thisvapor can be visualized both before inhalation and during exhalation ofthe medium. PG has some advantages as compared to glycerin alone, as itexhibits a much higher vapor pressure at equivalent temperature andallows the device to operate at a lower temperature. Reducing theoperating temperature conserves energy, and potentially can furtherimprove the health benefits of using this system.

In some cases, vapor resulting from PG that is inhaled by the user canpartially absorb in the respiratory tract. If this occurs, it can appearas though the user is expelling primarily air. This differs from theconventional smoking experience in that in the case of smoking, userscan typically see and play with expelled smoke as they exhale. Becausethe visual vapor created by heating glycerin can be seen upon exhale,some preparation of fill material for this invention can comprise acombination of both glycerin and PG. In these embodiments, the PG allowsfor high densities of visual vapor which the user can see/experienceprior to inhaling as well as a tactile response in the respiratorytract, and the addition of glycerin allows for increased amounts ofvapor to be seen or otherwise experienced upon exhale.

One method of manufacturing the material for use in a device orcartridge of the invention is to combine cured tobacco leaves with theother ingredients at low heat, and then allow the mixture to incorporateor marinate at room temperature for an extended period of time, from oneday to as long as three weeks (depending on the particular recipe andflavors used). The material can then processed by chopping into evenconsistency with particles 1-2 mm in diameter and inserted into thecartridge, or directly into the device. Alternatively, the material canbe processed into a more even, paste-like consistency for improvedhandling in conventional pump equipment, as described herein.

Example methods of filling a material into a cartridge included an augerfill method and a piston pump method. Both of these are common fillprocesses used in the packing industry for food and pharmaceuticalgoods. Either method allows for loading a repeatedly controlled volumeof fill material (for example, about 0.25 cubic centimeters) into theshell. The filled shell can then be lidded using the heat-sealablelidding film. The fill and seal operations can be combined on anindexing machine known to those skilled in the art of food andpharmaceutical packaging.

IV. Uses

The device can emulate smoking by providing many of the desirableeffects of smoking required by a user. An example of a method of use ofa device and/or cartridge of the invention is demonstrated in FIG. 14. Avapor-forming medium as described herein can be combined with a tobaccomaterial and inserted into a device 1400 of the invention eitherdirectly or using a cartridge of the invention. The tobacco materialprovides to the user the inhalation of substances 1494, such asnicotine, but not many of the tar-type substances, such as many of theHoffmann analytes (see below), that accompany burning the tobaccomaterial. A device 1400 of the invention can be used in a similar mannerto a cigarette or other smoking article by placing the mouthpiece of thedevice 1400 into contact with the mouth 12 of a user 10. However,without the smoke or the feel of smoke, the user may not be satisfiedwith the experience. In order to provide a tactile response to theinhalation of the tobacco material, the vapor-forming medium 1494 can beadded, such as propylene glycol, that can be absorbed in the respiratorytract 14.

Also, when smoking a tobacco material, the smoke may provide a visualaide and/or visual recognition to the user. In order to provide asimilar visual aide, the vapor-forming medium may contain a substance,such as glycerin, that can be visualized before and during inhalation,as well as during exhalation. In an exemplary method of use demonstratedin FIG. 15, the user 10 has received inhaled tobacco substances from adevice 1500 of the invention in a manner that has reduced the Hoffmananalyte intake of the user 10 by at least 70%. After the intake of thesubstance, the user may exhale a visible vapor 1596 from thevapor-forming medium through the mouth 12. The visible vapor 1596 canprovide a similar visual aide to that of exhaled smoke in the act ofsmoking.

V. Hoffman Analytes

Cigarette smoke is a complex mixture of thousands of chemicalconstituents. Many of these have been linked to smoking-relatedillnesses. A standard reference on the more harmful compounds found incigarette smoke is the Hoffmann analytes list recognizing about 44different analytes that may be present in mainstream smoke. It is namedin honor of Dietrich Hoffmann, a biochemist and leading authority ontobacco carcinogenesis. This list contains chemicals commonly associatedwith the health risks of smoking. These analytes and chemicals include,for instance, ammonia, aminonaphthalenes, benzopyrene, formaldehyde,acetaldehyde, acetone, methyl ethyl ketone, butyraldehyde, hydrogencyanide, nitrous oxides, tobacco-specific nitrosamines (TSNAs),pyridine, quinoline, hydroquinone, phenol, cresols, tar, nicotine,carbon monoxide, 1,3-butadiene, isoprene, acrylonitrile, benzene,toluene, styrene, and various others. It has been determined that someHoffmann analytes may be unwanted in the mainstream smoke from a smokingarticle. As such, extensive research has been conducted on reducingHoffmann analytes. The Hoffmann analytes may also be carcinogenic and adevice for smoking or emulating smoking would be desirable.

Using a device of the invention, a tobacco material can be aerosolizedwithout burning the material. By aerosolizing the tobacco, many of theunwanted chemicals and Hoffmann analytes are not inhaled by the user.For example, a device of the invention can reduce the inhalation ofHoffmann analytes by about 70% or more. In some embodiments, a device ofthe invention can reduce the inhalation of Hoffmann analytes by about50% or more. In some embodiments, a device of the invention can reducethe inhalation of Hoffmann analytes by about 60% or more. In someembodiments, a device of the invention can reduce the inhalation ofHoffmann analytes by about 70% or more. In some embodiments, a device ofthe invention can reduce the inhalation of Hoffmann analytes by about80% or more. In some embodiments, a device of the invention can reducethe inhalation of Hoffmann analytes by about 90% or more.

VI. Ames Assay

The bacterial reverse mutation test was originally developed by Ames etal. The Ames assay serves as a predictor for compounds that might causecarcinogenesis in humans. The method has been widely adopted, and theFDA incorporates it as part of a more comprehensive study of toxicityfor new food additives and drugs. The same test has been widely used tostudy the toxicity of tobacco products and tobacco smoke. The Ames testis a biological assay to assess the mutagenic potential of chemicalcompounds. As cancer is often linked to DNA damage, the test also servesas a quick assay to estimate the carcinogenic potential of a compound.In comparison, the standard tests for carcinogenicity done on rodentstake years to complete and are expensive. The Ames test uses severalstrains of the bacterium Salmonella typhimurium that carry mutations ingenes involved in histidine synthesis, so that they require histidinefor growth. The variable being tested is the mutagen's ability to causea reversion to growth on a histidine-free medium. The tester strains arespecially constructed to have both frameshift and point mutations in thegenes required to synthesize histidine, which allows for the detectionof mutagens acting via different mechanisms. Some compounds are quitespecific, causing reversions in just one or two strains. The testerstrains also carry mutations in the genes responsible forlipopolysaccharide synthesis, making the cell wall of the bacteria morepermeable, and in the excision repair system to make the test moresensitive. Rat liver extract is added to simulate the effect ofmetabolism, as some compounds, like benzopyrene, are not mutagenicthemselves but their metabolic products are. In order to perform anassay, the bacteria are spread on an agar plate with a small amount ofhistidine. This small amount of histidine in the growth medium allowsthe bacteria to grow for an initial time and have the opportunity tomutate. When the histidine is depleted, only bacteria that have mutatedto gain the ability to produce histidine will survive. The plate isincubated for 48 hours. The mutagenicity of a substance is proportionalto the number of colonies observed.

As demonstrated in Example 2 below, device of the invention for use witha tobacco containing material can show significant improvement in Amesassay results as compared to many types of smoking tobacco. Thus, adevice of the invention can provide many of the substances of thetobacco, such as nicotine, to a user while not providing some keycarcinogenic components that are associated with the burning or smoke oftobacco.

EXAMPLE 1

Cigarette smoke is a complex mixture of thousands of chemicalconstituents. Many of these have been linked to smoking-relatedillnesses. The Hoffman analytes list is a standard reference on the moreharmful compounds found in cigarette smoke. A set of 52 target compoundswill be selected based on the Hoffman list. It is expected that thevapor produced by a device of the invention will reduce the levels ofthese target compounds by a significant amount (70% reduction orgreater).

Constituent testing of a prototype device of the invention and areference cigarette (KY2R4F) will be conducted in a laboratory. Samplesfrom both types of devices will be acquired onsite, in automated smokingmachines and under the Canadian Intense regime (55 cubic centimeter (cc)puffs every 30 seconds). It is believed that this method approximatesactual smoking conditions better than the FTC regime (35 cc puffs every60 seconds). Arista has developed extensive protocols for the analysisof the target compounds, based on literature. These protocols will beemployed for testing. Methods of collection and extraction for eachgroup of analyte are summarized in TABLE 1.

TABLE 1 Hoffman Analyte Analysis Analyte Collection method ExtractionMethod Analysis Method Ammonia Five cigarettes through a The pad isextracted with Ion chromatography (IC) 44-mm Cambridge filter theimpinger solutions. with a Dionex IonPac CS14 pad with two impingerscation exchange analytical containing 20 ml of 0.01 N MSA. column.Aromatic Amines Five cigarettes through a Extract pad with 5% HCl Gaschromatography-mass 2-Aminonaphthalene 44-mm Cambridge filter andinternal standards. spectrometry selective ion 3-Aminobiphenyl pad.Liquid-liquid extraction monitoring (GC/MS SIM) 4-Aminobiphenyl withdichloromethane. The with a J&W DB5MS, 30- (3 total) eluent is collectedand then m × 0.25-mm × 0.25-μm film concentrated. thickness.Trimethylamine is added and the extract is derivatized withpentafluoropropionic anhydride. The resultant solution is eluted througha florisil column and then concentrated before analysis. PolynuclearAromatic Five cigarettes through a Add internal standard and GC/MS SIMwith a J&W Hydrocarbons 44-mm Cambridge filter then extract pad withDB5MS, 30-m × 0.25-mm × Benz(a)anthracene pad. mixture of cyclohexaneand 0.25-μm film thickness. Benzo(b)fluoranthene benzene. Filter througha Benzo(j)fluoranthene silica solid phase extractionBenzo(k)fluoranthene (SPE) cartridge and Benzo(a)pyrene concentrate. Adda mixture Chrysene of 33% methanol in water Dibenz(a,h)anthracene andput through a C18 SPE Dibenzo(a,i)pyrene cartridge. Wash with 30%Dibenzo(a,l)pyrene methanol in water and Indeno(1,2,3-c,d)pyrene extractwith 1.5 mL of 5-Methylchrysene benzene for analysis. (11 total)Carbonyls One cigarette through two The impinger solutions areHigh-pressure liquid Formaldehyde impingers containing combined. Analiquot is chromatography with UV Acetaldehyde 25 mL of 2,4- removed,pyridine is added detector (HPLC-UV) with a Acetonedinitrophenylhydrazine and to the aliquot and the reversed phase, C18,250- Acrolein perchloric acid in solution is analyzed. mm × 4.6-mmcolumn. Propionaldehyde acetonitrile. Crotonaldehyde ButyraldehydeMethylethylketone (8 total) Hydrogen Cyanide Mainstream smoke is TheCambridge filter pad is The gas and particulate collected from one tothree extracted with 0.1N sodium phases are analyzed cigarettes througha 44-mm hydroxide. The impinger separately by continuous Cambridgefilter pad solution is shaken by hand. flow analysis. followed by oneimpinger containing 0.1 N sodium hydroxide. Carbon Monoxide The gasphase smoke is Not Applicable The concentration of CO is collected in agas-sampling determined using a non- bag. dispersive infraredspectrometer (NDIR spectrometer). Nitric Oxide Puff-by-puff on-line NotApplicable The gaseous phase smoke is analysis. passed through a NOchemiluminescence detector. Mercury Hg is trapped in impingers Thesamples are microwave Flow injection, cold vapor containing potassiumdigested. atomic absorption permanganate. spectrometry (cold vapor AA)Metals The smoke is trapped in an The CSC is first extracted Analysis byinductively Nickel electrostatic precipitation using methanol and thenthe coupled plasma mass Lead unit. solvent is evaporated beforespectrometry (ICP-MS). Cadmium digestion with heat and Chromium nitricacid. Arsenic Selenium (6 total) Nitrosamines Five cigarettes through aExtraction of filter with Liquid chromatography NNN 44-mm Cambridgefilter 0.1N ammonium acetate. tandem mass spectrometry NNK pad.(LC-MS/MS) with NAT electrospray ionization NAB (ESI) using a 2.0 × 50mm (4 total) C18 column. Semi-Volatiles Three to five cigarettes Thefilter pad and impinger Gas chromatography-mass Pyridine through a 44-mmsolution are combined. spectrometry (GC/MS) with 3-VinylpyridineCambridge filter pad Internal standards are added a J&W DB-Wax, 30-m ×Quinoline followed by an impinger with orbital agitation. The 0.25-mm ×0.25-μm film (3 total) containing methanol and resultant solution isthickness. triethanolamine (TEA). decanted and analyzed. Phenols Fivecigarettes through a Extraction using a 1% HPLC/Fluorescence with aCatechol 44-mm Cambridge filter acetic acid in 30% methanolreversed-phase column. Phenol pad. with agitation for 60 Hydroquinoneminutes. Filter an aliquot of Resorcinol the extract and then m- &p-Cresol analyze. o-Cresol (6 total) Volatiles Three to five cigarettesThe filter pad and cold GC/MS with a J&W 1,3-Butadiene through a 44-mmimpinger solution are DB5MS, 60-m × 0.25-mm × Isoprene Cambridge filterpad combined. Internal 1.0-μm film thickness Acrylonitrile followed byan impinger standards are added and the column. Benzene containingmethonal solution is vortexed briefly. Toluene maintained at sub-ambientThe resultant solution is Styrene temperature. decanted and analyzed. (6total)

For each target compound, five replicate tests will be run, both for adevice of the invention and the reference cigarette. The differences inmean yield between the two articles will be determined as a percentage.It is expected that a device of the invention will reduce the level ofHoffman analytes by about 70% or more as compared to the referencecigarette.

EXAMPLE 2

The bacterial reverse mutation test, or “Ames assay,” serves as apredictor for compounds that might cause carcinogenesis in humans. Thistest has been widely used to study the toxicity of tobacco products andtobacco smoke. The objective of this study described here was to screenthe smoke condensate of the present invention for mutagenicity in the TA98 strain of the bacterium Salmonella typhimurium using the Ames assay.Strain TA 98 was chosen because it is among the most sensitive strainsof Salmonella typhimurium, and can detect a wide variety of mutagens. Ifa dose-dependent response is detected, the smoke condensate isconsidered to be mutagenic for that strain.

Testing facility. Test article preparation (i.e., “smoking” andextraction), chemical constituent analysis and genotoxicity wereconducted at Arista Laboratories, 1941 Reymet Road, Richmond, Va. 23237.

Preparation of extracts of test articles. Three cartridges were “smoked”per each replicate using a smoking device of the present inventionconnected to an automated rotary smoking machine (Borgwaldt RM-20 CSR)using the following parameters: 1) puff volume of 55 ml; and 2) puffduration of 30 seconds and an air flow according to ISO standards. TotalParticulate Matter (TPM) phase was collected onto a 44 mm Cambridgefilter pad and extracted into dimethyl sulfoxide (DMSO). Immediatelyfollowing extraction, TPM samples were aliquoted into individual ambervials and stored at less than or equal to −70° C. for greater than orequal to 48 h prior to testing by the Ames assay. Once thawed and usedfor testing, TPM extracts were not reused or refrozen.

Mutagenicity testing (Ames assay). The Ames assay was conducted on TPMextracts generated during three independent “smoking” sessions. Theassay was performed according to according to Arista Standard OperatingProcedure # TOX 001. TPM samples were tested in triplicate with theaddition of an exogenous metabolic activation system (S9). For eachreplicate sample, ten concentrations of particulate phase ranging from0-2000 μg TPM per plate were tested in a minimum of three plates perconcentration. Concurrent testing of strain-specific positive controls(with and without S9) and a single concentration (i.e., 100 μg) of theKY2R4F reference cigarette condensate were conducted. The assay wasconducted according to Health Canada Official Method 501, secondedition, 2004-11-01, Arista Standard Operating Procedure # TOX 001.Results of the Ames assay are shown in FIG. 16. Vehicle and positivecontrols, KY2R4F and spontaneous revertant concurrently run with eachtest and pertinent to bacteria strains and incubation conditions werewithin the expected laboratory control limits or deemed scientificallyacceptable by the study director.

Results. As shown in FIG. 16, the study found no dose-dependent effectof the Total Particulate Matter (TPM) generated by “smoking” the deviceof the present invention. Moreover, all TPM samples showed a reversionrate less than half that of the control. In contrast, published data forthe “1R4F” Kentucky reference cigarette, a cigarette of common tobaccoand filter composition, produce a positive-sloping trend for the TA 98tester strain. See D. W. Bombick et al., “Chemical and BiologicalStudies of a New Cigarette that Primarily Heats Tobacco. Part 3. Invitro toxicity of whole smoke,” Food and Chemical Toxicology, 36:183-190(1997).

Although preferred embodiments of the present invention have been shownand described herein, it will be obvious to those skilled in the artthat such embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein can be employed in practicing the invention. It is intended thatthe following claims define the scope of the invention and that methodsand structures within the scope of these claims and their equivalents becovered thereby.

1. A cartridge for use in a device for aerosolizing a materialcomprising: (a) a shell for containing a viscous vaporizable material;and (b) a lid sealed upon the shell, thereby forming a sealed cartridgecontaining a viscous vaporizable material.
 2. The cartridge of claim 1,wherein the lid is penetrable.
 3. The cartridge of claim 1, wherein apenetrated lid allows an exit of an aerosol generated from heating theviscous vaporizable material.
 4. The cartridge of claim 1, wherein thelid is a heat-sealable film.
 5. The cartridge of claim 4, wherein theheat-sealable film comprises a base layer and a heat-sealable layer. 6.The cartridge of claim 1, wherein the lid comprises aluminum.
 7. Thecartridge of claim 1, wherein the shell comprises aluminum.
 8. Thecartridge of claim 1, wherein the shell comprises a flange.
 9. Thecartridge of claim 8, wherein the lid is sealed upon the flange.
 10. Thecartridge of claim 1, wherein the cartridge is heated to a temperaturerequired to aerosolize the material contained within the shell.
 11. Thecartridge of claim 10, wherein the cartridge is heated to less than 400°F.
 12. The cartridge of claim 1, wherein the cartridge is inserted intoa device wherein the device is capable of aerosolizing the viscousvaporizable material.
 13. The cartridge of claim 12, wherein thecartridge is inserted into an oven chamber of the device.
 14. Thecartridge of claim 1, wherein information is printed on at least one ofthe shell and the lid.
 15. The cartridge of claim 1, wherein the viscousvaporizable material comprises an aerosol-forming medium.
 16. Thecartridge of claim 15, wherein the aerosol-forming medium comprises atleast one of propylene glycol and glycerin.
 17. The cartridge of claim1, wherein the viscous vaporizable material comprises tobacco.
 18. Amethod of filling a cartridge containing a viscous vaporizable materialcomprising: (a) loading a the viscous vaporizable material into a shellof the cartridge; and (b) sealing a lid on the shell of the cartridge.19. The method of claim 18, wherein the method is automated.
 20. Themethod of claim 19, wherein the method is carried out on a linear orrotating indexing machine.
 21. The method of claim 18, wherein theloading step comprises an auger filler method.
 22. The method of claim18, wherein the loading step comprises a piston pump method.
 23. Themethod of claim 18, wherein a predetermined volume of viscousvaporizable material is loaded in the loading step.
 24. The method ofclaim 23, wherein the volume is about 0.1 to about 0.8 cubiccentimeters.
 25. The method of claim 24, wherein the volume is about0.25 cubic centimeters.
 26. The method of claim 18, wherein the sealingstep comprises heating at least one of the lid and the shell of thecartridge.
 27. The method of claim 18 further comprising trimming anyexcess material from the lid.
 28. A device for generating an inhalableaerosol comprising: (a) a body; (b) a heater within the body capable ofheating a viscous vaporizable material to a generate an inhalableaerosol; and (c) a temperature regulator comprising one or morebimetallic discs, wherein the discs are configured and adapted toconvert a temperature change into mechanical displacement.
 29. Thedevice of claim 28, wherein the heater is supplied with gaseous fuel.30. The device of claim 28, wherein the discs displace a pushrod. 31.The device of claim 30, wherein the pushrod limits or ceases flow of thegaseous fuel within the body of the device.
 32. The device of claim 31,wherein the pushrod limits or ceases flow of the gaseous fuel by pushingon a variable flow-restricting valve.
 33. The device of claim 31,wherein the pushrod supports a catalytic mesh element.
 34. The device ofclaim 28, wherein the heater is ignited by a piezoelectric igniter. 35.The device of claim 28, wherein the inhalable aerosol comprisesparticles less than about 2 microns in diameter.
 36. A device whichemulates smoking wherein the device generates an aerosol for inhalationby a subject by heating a viscous material containing plant matter toabout 150° C. and wherein the aerosol has a tactile response in themouth or respiratory tract.
 37. The device of claim 36, wherein theviscous material comprises an aerosol-forming medium.
 38. The device ofclaim 37, wherein the aerosol-forming medium comprises at least one ofpropylene glycol and glycerin.
 39. The device of claim 38, wherein theat least one of propylene glycol and glycerin produces a visual aerosolwhen heated.
 40. The device of claim 36, wherein an active element thatis part of the aerosol is absorbed in the respiratory tract.
 41. Thedevice of claim 36, wherein the viscous material comprises tobacco. 42.The device of claim 36, wherein the viscous material further comprisesflavorants.
 43. The device of claim 36, wherein the aerosol comprisesparticles less than about 2 microns in diameter.
 44. A device comprisinga body and a heater wherein the device generates a smokeless aerosol forinhalation by a subject by heating a viscous tobacco material to atarget temperature.
 45. The device of claim 44, wherein the viscoustobacco material comprises an aerosol-forming medium.
 46. The device ofclaim 45, wherein the aerosol-forming medium comprises at least one ofpropylene glycol and glycerin.
 47. The device of claim 46, wherein theat least one of propylene glycol and glycerin produces a visual aerosolwhen heated.
 48. The device of claim 44, wherein an active element thatis part of the aerosol is absorbed in the respiratory tract.
 49. Thedevice of claim 44, wherein the viscous tobacco material furthercomprises flavorants.
 50. The device of claim 44, wherein the targettemperature is about 100° C. to about 200° C.
 51. The device of claim50, wherein the target temperature is about 150° C.
 52. The device ofclaim 44, wherein the device can be operated by a user with a singlehand.
 53. The device of claim 44, wherein the smokeless aerosolcomprises particles less than about 2 microns in diameter.
 54. Anaerosol generating device wherein the device generates an aerosolsubstantially free from at least one Hoffman analyte upon heating asmokeable material to a target temperature.
 55. The device of claim 54,wherein the Hoffman analyte is selected from the group consisting of:ammonia, aminonaphthalenes, benzopyrene, formaldehyde, acetaldehyde,acetone, methyl ethyl ketone, butyraldehyde, hydrogen cyanide, nitrousoxides, tobacco-specific nitrosamines (TSNAs), pyridine, quinoline,hydroquinone, phenol, cresols, tar, nicotine, carbon monoxide,1,3-butadiene, isoprene, acrylonitrile, benzene, toluene, and styrene.56. The device of claim 54, wherein the target temperature is about 100°C. to about 200° C.
 57. The device of claim 56, wherein the targettemperature is about 150° C.
 58. The device of claim 54, wherein theaerosol comprises particles less than about 2 microns in diameter. 59.An aerosol generating device wherein the device generates an aerosolupon heating a smokeable material to a target temperature with at least70% less Hoffman analytes than a common tobacco cigarette.
 60. Thedevice of claim 59, wherein the Hoffman analyte is selected from thegroup consisting of: ammonia, aminonaphthalenes, benzopyrene,formaldehyde, acetaldehyde, acetone, methyl ethyl ketone, butyraldehyde,hydrogen cyanide, nitrous oxides, tobacco-specific nitrosamines (TSNAs),pyridine, quinoline, hydroquinone, phenol, cresols, tar, nicotine,carbon monoxide, 1,3-butadiene, isoprene, acrylonitrile, benzene,toluene, and styrene.
 61. The device of claim 59, wherein the targettemperature is about 100° C. to about 200° C.
 62. The device of claim61, wherein the target temperature is about 150° C.
 63. The device ofclaim 59, wherein the common tobacco cigarette comprises a filter. 64.The device of claim 59, wherein the aerosol comprises particles lessthan about 2 microns in diameter.
 65. A method of delivering an aerosolsubstantially free from a Hoffman analyte to a subject comprising: (a)deploying an aerosol generating device containing a heater and asmokeable material; (b) heating the smokeable material with the heaterof the device to a target temperature to generate an aerosol; and (c)delivering the aerosol to the subject for inhalation.
 66. The device ofclaim 65, wherein the aerosol comprises particles less than about 2microns in diameter.
 67. A method of creating a tactile response in themouth or respiratory tract comprising: (a) deploying a smoke emulatingdevice wherein the device generates a smokeless aerosol having a tactileresponse in the mouth or respiratory tract by heating a viscous materialcontaining plant matter contained therein; (b) heating the viscousmaterial to a target temperature; (c) generating an aerosol having thetactile response in the mouth or respiratory tract from the heatedviscous material; and (d) inhaling the aerosol.
 68. The method of claim67, wherein the viscous material comprises an aerosol-forming medium.69. The method of claim 68, wherein the aerosol-forming medium comprisesat least one of propylene glycol and glycerin.
 70. The method of claim69, wherein the at least one of propylene glycol and glycerin produces avisual aerosol when heated.
 71. The method of claim 67, wherein anactive element that is part of the aerosol is absorbed in therespiratory tract.
 72. The method of claim 67, wherein the viscousmaterial comprises tobacco.
 73. The method of claim 67, wherein theviscous material further comprises flavorants.
 74. The method of claim67, wherein the target temperature is about 100° C. to about 200° C. 75.The method of claim 74, wherein the target temperature is about 150° C.76. The method of claim 67, wherein the aerosol comprises particles lessthan about 2 microns in diameter.
 77. An aerosol generating devicewherein the device generates an aerosol from a smokeable materialwherein the aerosol contains at least 70% less Hoffman analytes than asubstance generated by burning the smokeable material.
 78. An aerosolgenerating device wherein the device generates an aerosol from asmokeable material wherein a particulate generated by the device yieldsa non-mutagenic Ames test result.
 79. An aerosol generating devicewherein the device generates an aerosol from a smokeable materialwherein the aerosol scores significantly better on the Ames test than asubstance generated by burning the smokeable material.
 80. An aerosolgenerating device wherein the device provides an aerosol for inhalationto a user for at least 4 non-continuous hours without servicing thedevice.